北京株水痘疫苗生产工艺的建立

目的:建立北京株水痘疫苗生产工艺,采用此生产工艺生产水痘减毒活疫苗。方法:采用细胞工厂培养2BS细胞,感染北京株水痘-带状疱疹病毒工作种子批,同时感染Oka株水痘-带状疱疹病毒工作种子批作对照,经洗涤、离心、收获、原液合并、冻干制备水痘减毒活疫苗,并进行各项检定。结果:对照两种不同毒株生产的水痘减毒活疫苗无明显差异,且各项检测指标均符合要求。结论:根据结果显示,可使用此毒株生产工艺大规模生产北京株水痘疫苗,与Oka株生产水痘疫苗无差异。如果用此毒株生产水痘疫苗供应市场,将会打破Oka株水痘疫苗国内市场的垄断。

Objective: Establish Beijing strains of varicella vaccine production technology, using it to produce VZV live attenuated varicella vaccine。 Methods: 2BS cells were cultivated in cell factories, Inoculated with Beijing-7 strains of varicella-zoster virus when it grows into thick monolayer.At the same time, inoculated with VZV Oka strains of varicella- zoster virus which was used as a synchronous control trials,When CPE appearedin in the cells infected with VZV, Washing、Centrifugal and harvested virus from the cells.VZV live attenuated vaccine was prepared by combining liquid and Lyophilization.Finally test these samples.Results: VZV live attenuated vaccines prepared by these two different strains have no significant differences, And the testing are qualified. Conclusion: According to the results, VZV live vaccine with Beijing strains can be mass-produced. It has no difference with Oka strains. Beijing strains?of varicella vaccine will break?the monopoly of the domestic market if we supply the production of this strain to market。